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Brief Title: Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Official Title: A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Study ID: NCT00135577
Brief Summary: Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain. Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Duarte, California, United States
GSK Investigational Site, Fountain Valley, California, United States
GSK Investigational Site, La Verne, California, United States
GSK Investigational Site, Sacramento, California, United States
GSK Investigational Site, San Diego, California, United States
GSK Investigational Site, New Port Richey, Florida, United States
GSK Investigational Site, Tampa, Florida, United States
GSK Investigational Site, West Des Moines, Iowa, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Worcester, Massachusetts, United States
GSK Investigational Site, St. Louis, Missouri, United States
GSK Investigational Site, Durham, North Carolina, United States
GSK Investigational Site, Hendersonville, North Carolina, United States
GSK Investigational Site, Tacoma, Washington, United States
GSK Investigational Site, Winnipeg, Manitoba, Canada
GSK Investigational Site, Saint John's, Newfoundland and Labrador, Canada
GSK Investigational Site, Kitchener, Ontario, Canada
GSK Investigational Site, Sudbury, Ontario, Canada
GSK Investigational Site, Bonaventure, Quebec, Canada
GSK Investigational Site, Chandler, Quebec, Canada
GSK Investigational Site, Sherbrooke, Quebec, Canada
GSK Investigational Site, Helsinki, , Finland
GSK Investigational Site, Bordeaux Cedex, , France
GSK Investigational Site, Strasbourg, , France
GSK Investigational Site, Vandoeuvre-Les-Nancy, , France
GSK Investigational Site, Villejuif Cedex, , France
GSK Investigational Site, Kwun Tong, , Hong Kong
GSK Investigational Site, Wellington, , New Zealand
GSK Investigational Site, Lahore, , Pakistan
GSK Investigational Site, Lima, , Peru
GSK Investigational Site, Bialystok, , Poland
GSK Investigational Site, Lublin, , Poland
GSK Investigational Site, Olsztyn, , Poland
GSK Investigational Site, Otwock, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Lisboa, , Portugal
GSK Investigational Site, Lisboa, , Portugal
GSK Investigational Site, Moscow, , Russian Federation
GSK Investigational Site, Alcorcon, , Spain
GSK Investigational Site, Nottingham, , United Kingdom
Name: GSK Clinical Trials, MD
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR